MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX SET; JOL CATHETER AND TIP, SUCTION

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: unknown.Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the guide wire of a wayne pneumothorax set was bent and unable to come back through the tip of the introducer.The trocar was unable to progress over the wire guide for insertion.This event occurred in the user facility's emergency department.No adverse effects to the patient have been reported.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: b5 this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

During the investigation, it was determined this event was inadvertently reported as it does not meet reporting criteria.

• Brand Name: WAYNE PNEUMOTHORAX SET
• Type of Device: JOL CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10251701
• MDR Text Key: 198331003
• Report Number: 1820334-2020-01278
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497-IMH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1